A Study to Assess the Safety and Tolerability of Single and Multiple Ascending Doses of Oral RO7020531 in Chinese Healthy Participants.

NCT ID: NCT03530917

Last Updated: 2020-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-15
• Study Completion Date: 2019-05-15

Brief Summary

To evaluate the safety and tolerability of single and multiple ascending doses of oral RO7020531 in Chinese healthy participants.

Conditions

Healthy Participants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Single Ascending Dose (SAD): Placebo

In SAD Cohorts 1-4, there will be eight participants in total receiving placebo, two in each cohort.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Placebo hard capsules will be administered orally as per the dosing schedules described above.

SAD: Cohort 1

Eight participants will be administered 40mg RO7020531 orally on Day 1.

Group Type: EXPERIMENTAL

RO7020531

Intervention Type: DRUG

4 SAD Cohorts with individual dosages of 40, 100, 140 and 170 mg hard capsules and 3 MAD Cohorts with dosages of 100 and 150mg hard capsules, will be administered orally as per the dosing schedules described above.

SAD: Cohort 2

Eight participants will be administered 100mg RO7020531 orally on Day 1.

Group Type: EXPERIMENTAL

RO7020531

Intervention Type: DRUG

4 SAD Cohorts with individual dosages of 40, 100, 140 and 170 mg hard capsules and 3 MAD Cohorts with dosages of 100 and 150mg hard capsules, will be administered orally as per the dosing schedules described above.

SAD: Cohort 3

Eight participants will be administered 140mg RO7020531 orally on Day 1.

Group Type: EXPERIMENTAL

RO7020531

Intervention Type: DRUG

4 SAD Cohorts with individual dosages of 40, 100, 140 and 170 mg hard capsules and 3 MAD Cohorts with dosages of 100 and 150mg hard capsules, will be administered orally as per the dosing schedules described above.

SAD: Cohort 4

Eight participants will be administered 170mg RO7020531 orally on Day 1.

Group Type: EXPERIMENTAL

RO7020531

Intervention Type: DRUG

4 SAD Cohorts with individual dosages of 40, 100, 140 and 170 mg hard capsules and 3 MAD Cohorts with dosages of 100 and 150mg hard capsules, will be administered orally as per the dosing schedules described above.

Multiple Ascending Dose (MAD): Placebo

In MAD Cohorts 1-3, there will be six participants in total receiving placebo, two in each cohort.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Placebo hard capsules will be administered orally as per the dosing schedules described above.

MAD: Cohort 1

Eight participants will be administered 100mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days.

Group Type: EXPERIMENTAL

RO7020531

Intervention Type: DRUG

4 SAD Cohorts with individual dosages of 40, 100, 140 and 170 mg hard capsules and 3 MAD Cohorts with dosages of 100 and 150mg hard capsules, will be administered orally as per the dosing schedules described above.

MAD: Cohorts 2 and 3

Sixteen participants will be administered 150mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days.

Group Type: EXPERIMENTAL

RO7020531

Intervention Type: DRUG

4 SAD Cohorts with individual dosages of 40, 100, 140 and 170 mg hard capsules and 3 MAD Cohorts with dosages of 100 and 150mg hard capsules, will be administered orally as per the dosing schedules described above.

Interventions

RO7020531

4 SAD Cohorts with individual dosages of 40, 100, 140 and 170 mg hard capsules and 3 MAD Cohorts with dosages of 100 and 150mg hard capsules, will be administered orally as per the dosing schedules described above.

Intervention Type: DRUG

Placebo

Placebo hard capsules will be administered orally as per the dosing schedules described above.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Chinese healthy male and female participants. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, and urinalysis.
• A Body Mass Index (BMI) of 19 to less than 28 kg/m2 and a body weight of at least 45 kg.
• Negative anti-nuclear antibody (ANA) test; or positive with dilutions not greater than 1:40 and with no associated history or symptoms of potential connective tissue disease or other immune-mediated diseases.
• Women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods.
• Men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and refrain from donating sperm.
• Negative pregnancy test on Day -1 for female participants.
• Non-smokers, or use of < 10 cigarettes (or equivalent nicotine-containing product) per day.

Exclusion Criteria

• Pregnant (positive pregnancy test) or lactating women, and male partners of women who are pregnant or lactating.
• History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis, multiple sclerosis, or any other autoimmune disease).
• History or symptoms of any clinically significant disease including (but not limited to), neurological, cardiovascular, endocrine, respiratory, hepatic, ocular, or renal disorder (as per Investigator's judgment).
• Personal or family history of congenital long QT syndrome or sudden cardiac death.
• Evidence of an active or suspected cancer or a history of malignancy, where in the Investigator's opinion, there is a risk of recurrence.
• History of having received or currently receiving any systemic anti-neoplastic (including radiation) or immune-modulatory treatment (including systemic oral or inhaled corticosteroids, IFN or PEG-IFN) within 6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study. Eye drop-containing and infrequent inhaled corticosteroids are permissible up to 4 weeks prior to the first dose of study drug.
• History of clinically significant thyroid disease; also, subjects with clinically significant elevated thyroid-stimulating hormone (TSH) concentrations at Screening.
• Any confirmed clinically significant allergic reactions (anaphylaxis) against any drug, or multiple drug allergies (non-active hay fever is acceptable).
• Abnormal renal function.
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values at Screening above ULN and judged clinically significant by the Investigator.
• Positive results for anti-mitochondrial antibody (AMA), anti-smooth muscle antibody (ASMA) or thyroid peroxidase antibody.
• Positive hepatitis A IgM antibody (HAV Ab IgM), hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), or positive for human immunodeficiency virus (HIV) at Screening.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Prince of Wales Hospital

Shatin, New Territories, , Hong Kong

Countries

Hong Kong

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

YP39553

Identifier Type: -

Identifier Source: org_study_id